Study name : International Neurological Study. A Stand Alone Study for Participant of A5175 “A Phase IV, Prospective, Randomized, Open-Label Evaluation Of The Efficacy Of Once-Daily Protease Inhibitor And Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations For Initial Treatment Of HIV-1 Infected Individuals Form Resource-Limited Settings (PEARLS) Trial
Project Code : A5199Study start : June 2005
Principle investigator : Professor Khuanchai Supparatpinyo, MD
Funding agency : The National Institute of Allergy and Infectious Diseases and The National Institute of Mental Health
Study sites :
1.Rio de Janeiro, Brazil
2.Porto Alegre, Brazil
Port-au-Prince, Haiti
3.Chennai, India
4.Pune, India
5.Blantyre, Malawi
6.Lilongwe, Malawi
7.Lima, Peru
8.Johannesburg, South Africa
9.Durban, South Africa
10.Chiang Mai University, Chiang Mai, THAILAND
11.Harare, Zimbabwe
Staudy start : June 2005
Study design : A two-step prospective, observational study
Study objectives
1 Estimate the prevalence of ADC in participants in resource-limited settings who have advanced disease (< 300 CD4+ cells/mm3) and who are treatment naïve.
2 Estimate the prevalence of HIV-related neurological opportunistic infections in participants in resource-limited settings who have advanced disease (< 300 CD4+ cells/mm3) and who are treatment naïve.
3 Estimate changes in neurocognitive functioning with initiation of antiretroviral regimen
in resource-limited settings
Significance : Knowledge with regards to neuropathology in HIV infected patients who are treated with variety of ARV regimens will help planning proper care for the patients in the future
Progression : The site enrolled 73 participants. According to the protocol team plan, the follow- up process will end by May 2010.
